Ciproxin 500mg Film-coated Tablets

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

CIPROFLOXACIN

Доступно од:

Bayer Public Limited Company

АТЦ код:

J01MA02

INN (Међународно име):

CIPROFLOXACIN

Фармацеутски облик:

TABLET

Састав:

CIPROFLOXACIN 500 milligram(s)

Тип рецептора:

POM

Терапеутска област:

ANTIBACTERIALS FOR SYSTEMIC USE

Статус ауторизације:

Authorised

Датум одобрења:

2006-11-27

Информативни летак

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIPROXIN 500MG FILM-COATED TABLETS
Ciprofloxacin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ciproxin is and what it is used for
2.
What you need to know before you take Ciproxin
3.
How to take Ciproxin
4.
Possible side effects
5.
How to store Ciproxin
6.
Contents of the pack and other information
1. WHAT CIPROXIN IS AND WHAT IT IS USED FOR
Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is
an antibiotic belonging to the
fluoroquinolone family. Ciprofloxacin works by killing bacteria that
cause infections. It only works
with specific strains of bacteria.
Adults
Ciproxin is used in adults to treat the following bacterial
infections:

respiratory tract infections

long lasting or recurring ear or sinus infections

urinary tract infections

genital tract infections in men and women

gastro-intestinal tract infections and intra-abdominal infections

skin and soft tissue infections

bone and joint infections

to prevent infections due to the bacterium
_Neisseria meningitidis_

anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients with low white
blood cell counts
(neutropenia) who have a fever that is suspected to be due to a
bacterial infection.
If you have a severe infection or one that is caused by more than one
type of bacterium, you may be
given additional antibiotic treatment in addition to Ciproxin.
Page 2 of 10
Children and adolescents
Ciproxin is u

Карактеристике производа

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ciproxin 500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg ciprofloxacin (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oblong, nearly white to slightly yellowish tablets marked with “CIP
score 500” on one side and
“BAYER” on the reverse side.
The tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ciproxin 500 mg film-coated tablets are indicated for the treatment of
the following infections (see
sections 4.4 and 5.1). Special attention should be paid to available
information on resistance to
ciprofloxacin before commencing therapy.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
Adults

Lower respiratory tract infections due to Gram-negative bacteria
-
exacerbations of chronic obstructive pulmonary disease
-
broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
-
pneumonia

Chronic suppurative otitis media

Acute exacerbation of chronic sinusitis especially if these are caused
by Gram-negative
bacteria

Urinary tract infections

Genital tract infections
- gonococcal uretritis and cervicitis due to susceptible
_Neisseria gonorrhoeae_
- epididymo-orchitis including cases due to susceptible
_Neisseria gonorrhoeae_
- pelvic inflammatory disease including cases due to susceptible
_Neisseria gonorrhoeae _

Infections of the gastro-intestinal tract (e.g. travellers’
diarrhoea)
Page 2 of 23

Intra-abdominal infections

Infections of the skin and soft tissue caused by Gram-negative
bacteria

Malignant external otitis

Infections of the bones and joints

Prophylaxis of invasive infections due to
_Neisseria meningitidis _

Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be used in the management of neutropenic patients
with feve